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VOLULYTE 6% SOLUTION FOR INFUSION

Active substance(s): HYDROXYETHYL STARCH 130/0.4 / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE

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0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Volulyte 6% solution for infusion
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
 This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting any
side effects you may get. See the end of section 4 for how to report
side effects.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
- If you get any side effects, talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Volulyte is and what it is used for
2. What you need to know before you use Volulyte
3. How to use Volulyte
4. Possible side effects
5. How to store Volulyte
6. Contents of the pack and other information
1. What Volulyte is and what it is used for
Volulyte is a plasma volume substitute that is used to restore the blood
volume when you have lost blood when other products called
crystalloids are not considered sufficient alone.

0xxxxx1/00 UK

1

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 2

2. What you need to know before you use Volulyte
Do not use Volulyte if you:
• are allergic to any of the active substances or any of the other
ingredients of this medicine
• suffer from serious generalised infection (sepsis)
• suffer from burn injury
• have kidney impairment or receive dialysis
• suffer from bleeding in the brain (intracranial or cerebral bleeding)
• are critically ill (e.g. you need to stay in an intensive care unit)
• have too much fluid in your body and you have been told that you
have a condition known as hyperhydration
• have fluid in the lungs (pulmonary oedema)
• are dehydrated
• have been told that you have a severe increase of potassium,
sodium or chloride in your blood
• have severely impaired liver function
• have severe heart failure
• have severe problems with your blood clotting
• have received an organ transplant
Warnings and Precautions
It is important to tell your doctor if you have:
• impairment of your liver function
• problems with your heart or circulation
• blood clotting (coagulation) disorders
• problems with your kidneys
• increased potassium, sodium, magnesium, chloride or alkaline levels
in your blood (hyperkalaemia, hypernatraemia, hypermagnesaemia,
hyperchloraemia)
Because of the risk of allergic (anaphylactic/anaphylactoid) reactions,
you will be monitored closely to detect early signs of an allergic reaction
when you receive this medicine.
Surgery and trauma:
Your doctor will consider carefully if this medicine is suitable for you.
Your doctor will adjust the dose of Volulyte carefully in order to prevent
fluid overload. This will be done especially if you have problems with
your lungs or with your heart or circulation.

2

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 3

The nursing staff will also take measures to observe your body's fluid
balance, blood salt level, and kidney function. If necessary you may
receive additional salts.
In addition it will be ensured that you receive enough fluids.
Volulyte is contraindicated if you have kidney impairment or kidney injury
requiring dialysis.
If impaired kidney function occurs during therapy:
If the doctor detects first signs of kidney impairment he/she will stop
giving you this medicine. In addition your doctor may need to monitor
your kidney function for up to 90 days.
If you are given Volulyte repeatedly your doctor will monitor the ability of
your blood to clot, bleeding time and other functions. In case of an
impairment of the ability of your blood to clot, your doctor will stop
giving you this medicine.
If you are undergoing open heart surgery and you are on a heart-lung
machine to assist in pumping your blood during the surgery, the
administration of this solution is not recommended.
Children
The safety of this product has not been assessed in children. Data are
limited in children, therefore it is recommended not to use HES
products in this population.
Other medicines and Volulyte
Tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, To date, Volulyte is not known to have any
interactions with other medicines.
Volulyte with food and drink
Volulyte is not known to have any negative effect when given at the
same time as food or drink.
Pregnancy and breast-feeding
For Volulyte no clinical data on exposed pregnancies are available.
The safety of the product in pregnant and breast-feeding women has
not been investigated. There are limited clinical study data available
from the use of a single dose of HES 130/0.4 (6%) in 0.9% sodium

3

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 4

chloride in pregnant women undergoing caesarean section with spinal
anesthesia. No negative influence of HES 130/0.4 (6%) in 0.9% sodium
chloride on patient safety could be detected; a negative influence on
the neonate could also not be detected.
Your doctor will only give Volulyte after having weighed the benefits
versus the potential risk to the baby.
Driving and using machines
After receiving Volulyte, your ability to drive a car or operate machinery
will not be affected.
3. How to use Volulyte
Volulyte will be given by, or under the direct supervision of, your
physician, who will closely control the amount of Volulyte given to you.
Mode of administration
You will receive this medicine by infusion into a vein (intravenous drip).
The speed of infusion, along with the amount of solution infused, will
depend on your specific requirements, the disease for which the
product is being used, and by reference to maximum daily dose.
Dosage
Your doctor will decide on the correct dose for you to receive.
Your doctor will use the lowest possible effective dose and will not
infuse Volulyte for more than 24 hours.
The maximum daily dose is 30 ml/kg for Volulyte.
Use in children
There is only limited experience of the use of this medicine in children.
Therefore it is not recommended to use this medicine in children.
If you have received more Volulyte than you should
Your doctor will ensure that you receive the right amount of Volulyte.
However, different people need different doses, and if the dose does
prove too much for you, your doctor may stop Volulyte immediately
and, if necessary, administer a medicine that removes water from the
body (diuretic).
If you have any further questions on the use of this product, please ask
your doctor or pharmacist.

4

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 5

4. Possible side effects
Like all medicines, Volulyte can cause side effects, although not
everybody gets them.
Common (may affect up to 1 in 10 people)
• Itching is a known side effect of hydroxyethyl starches when used
over long periods of time and at high doses.
• Other effects are associated with the dilution of the blood, which
occurs at high dosages, such as prolonged blood clotting time.
• The level of the enzyme serum amylase can rise during administration
of hydroxyethyl starch and can interfere with the diagnosis of
inflammation of the pancreas (pancreatitis). However, in this case the
elevated serum amylase level must not be considered diagnostic of
pancreatitis.
Rare (may affect up to 1 in 1,000 people)
• Medicinal products containing hydroxyethyl starch may lead to
severe allergic reactions (reddening of the skin, swelling of the throat,
and difficult breathing, mild influenza like symptoms, low or high
heart rate, fluid in the lungs not caused by heart problems).
• After administration of hydroxyethyl starch disturbances of blood
clotting can occur depending on the dose.
Frequency not known (cannot be estimated from the available data)
• Kidney injury
• Liver injury
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly:
For UK: via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For IE: Reports may be made by following the links to the online reporting
option accessible from the IMB homepage, or by completing the
downloadable report form also accessible from the IMB website, which
may be completed manually and submitted to the IMB via freepost, to
the following address:

5

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 6

IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie.
For MT: to the Medicines Authority at the following contact details
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Volulyte
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not freeze.
Do not use Volulyte after the expiry date which is stated on the label.
The expiry date refers to the last day of that month.
Your doctor or nurse will ensure that the solution is clear, free from
particles, the container undamaged and the overwrap is removed from
the polyolefin (freeflex) bag before use.
The solution should be used immediately after opening, and any solution
remaining after treatment should be discarded. For single use only.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 7

6. Contents of the pack and other information
What Volulyte contains
1000 ml solution for infusion contain:
Active substances:
Poly(O-2-hydroxyethyl)starch (Ph. Eur.)
60.00 g
- Molar substitution: 0.38 – 0.45
- Mean molecular weight (Mw):
130,000 Da
(manufactured from waxy maize starch)
Sodium acetate trihydrate
4.63 g
Sodium chloride
6.02 g
Potassium chloride
0.30 g
Magnesium chloride hexahydrate
0.30 g
Electrolytes:
Na+
K+
Mg++
ClCH3COO-

137.0 mmol/l
4.0 mmol/l
1.5 mmol/l
110.0 mmol/l
34.0 mmol/l

Theoretical osmolarity:
Titratable acidity:
pH:

286.5 mosm/l
< 2.5 mmol NaOH/l
5.7 – 6.5

Other ingredients: Sodium hydroxide, hydrochloric acid, water for injections.
What Volulyte looks like and contents of the pack
Volulyte is a sterile, clear to slightly opalescent solution, colourless to
slightly yellow. It is contained in:
• flexible bags made of polyolefin (freeflex) or
• in a glass bottle.
All container types are available in 250 ml and 500 ml sizes.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire, WA7 1NT, UK

7

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 8

Manufacturer:
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria: Volulyte 6% Infusionslösung
Belgium: Volulyte 6% oplossing voor infusie
Bulgaria: Volulyte 6% solution for infusion
Cyprus: Volulyte 6% Solution for Infusion
Czech Republic: Volulyte 6%
Denmark: Volulyte
Estonia: Volulyte 6% infusioonilahus
Finland: Volulyte 60 mg/ml infuusioneste, liuos
Germany: Volulyte 6% Infusionslösung
Greece: Volulyte 6% Solution for Infusion
Hungary: Volulyte 6% oldatos infúzió
Ireland: Volulyte 6% Solution for Infusion
Iceland: Volulyte 60 mg/ml innrennslislyf, lausn
Italy: Volulyte 6% Soluzione per infusione
Lithuania: Volulyte 6% infuzinis tirpalas
Latvia: Volulyte 6% škidums infuzijam
Luxembourg: Volulyte 6% Infusionslösung
Malta: Volulyte 6% Solution for Infusion
Netherlands: Volulyte 6% oplossing voor infusie
Norway: Volulyte 60 mg/ml infusjonsvæske, oppløsning

8

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 9

Poland: Volulyte 6%
Portugal: Volulyte Solução para Perfusão
Romania: Volulyte 6%, solutie perfuzabila
Sweden: Volulyte 60 mg/ml infusionvätska, lösning
Slovakia: Volulyte 6%, infúzny roztok
Slovenia: Volulyte 60mg/ml raztopina za infundiranje
Spain: Volulyte 6% solución para perfusión
UK: Volulyte 6% Solution for Infusion
This leaflet was last revised in 02/2016.

9

0xxxxx1_Volulyte_06_UK_PB 11.02.2016 11:31 Seite 10

The following information is intended for healthcare professionals only:
Use of HES should be restricted to the initial phase of volume
resuscitation with a maximum time interval of 24 h.
The maximum daily dose is 30 ml/kg for Volulyte.
The lowest possible effective dose should be applied. Treatment should
be guided by continuous haemodynamic monitoring so that the infusion
is stopped as soon as appropriate haemodynamic goals have been
achieved. The maximum recommended daily dose must not be exceeded.
The first 10-20 ml should be infused slowly and under careful
monitoring of the patient so that any anaphylactic/anaphylactoid
reaction can be detected as early as possible.
The duration of treatment depends on:
• he extent of the low blood volume
• blood pressure
• the dilution of blood and its components (platelets, red blood cells
etc.).
Use in children
Data are limited in children, therefore it is recommended not to use HES
products in this population.
For single use only.
The product should be used immediately after first opening.
Any unused product or waste material should be disposed of in
accordance with local requirements.
Use only clear, particle-free solutions and undamaged containers.
Remove the overwrap from the Polyolefin (freeflex) bag prior to use.

V005

10

Theoretical osmolarity:
Titratable acidity:
pH:

16:41 Uhr

Seite 1

286.5 mosm/l
< 2.5 mmol NaOH/l
5.7– 6.5

Use of HES should be restricted to the initial phase of volume
resuscitation with a maximum time interval of 24 h.

Other ingredients: Sodium hydroxide, hydrochloric acid, water for injections.
What Volulyte looks like and contents of the pack
Volulyte is a sterile, clear to slightly opalescent solution, colourless to slightly
yellow. It is contained in:
• flexible bags made of polyolefine (freeflex) or
• in a glass bottle
All container types are available in 250 ml and 500 ml sizes.

The maximum daily dose is 30 ml/kg for Volulyte.

Volulyte 6%

The lowest possible effective dose should be applied. Treatment should be
guided by continuous haemodynamic monitoring so that the infusion is
stopped as soon as appropriate haemodynamic goals have been achieved.
The maximum recommended daily dose must not be exceeded.

solution for infusion
Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution

The first 10 – 20 ml should be infused slowly and under careful monitoring
of the patient so that any anaphylactic/anaphylactoid reaction can be detected
as early as possible.

Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire, WA7 1NT, UK
Manufacturer:
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v. d. H.
This medicinal product is authorised in the Member States of the EEA under
the following names:
Austria:
Belgium:
Bulgaria:
Cyprus:
Czech Republic:
Denmark:
Estonia:
Finland:
Germany:
Greece:
Hungary:
Ireland:
Iceland:
Italy:
Lithuania:
Latvia:
Luxembourg:
Malta:
Netherlands:
Norway:
Poland:
Portugal:
Romania:
Sweden:
Slovakia:
Slovenia:
Spain:
UK:

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following information is intended for healthcare professionals only:

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. You can help by reporting any side effects you may get. See the end of section 4 for how to
report side effects.

The duration of treatment depends on:
• the extent of the low blood volume
• blood pressure
• the dilution of blood and its components (platelets, red blood cells etc.).

Read all of this leaflet
carefully before you
start using this
medicine because it
contains important
information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, pharmacist or nurse.
– This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

Use in children
Data are limited in children, therefore it is recommended not to use HES
products in this population.

What is in this leaflet

1. What Volulyte is and what it is used for
2. What you need to know before you use Volulyte
3. How to use Volulyte
4. Possible side effects
5. How to store Volulyte
6. Contents of the pack and other information

1. What Volulyte is and
what it is used for

Volulyte is a plasma volume substitute that is used to restore the blood
volume when you have lost blood when other products called crystalloids
are not considered sufficient alone.

2. What you need to
know before you
use Volulyte

Do not use Volulyte if you:
• are allergic to any of the active substances or any of the other
ingredients of this medicine
• suffer from serious generalised infection (sepsis)
• suffer from burn injury
• have kidney impairment or receive dialysis
• suffer from bleeding in the brain (intracranial or cerebral bleeding)
• are critically ill (e.g. you need to stay in an intensive care unit)
• have too much fluid in your body and you have been told that you
have a condition known as hyperhydration
• have fluid in the lungs (pulmonary oedema)
• are dehydrated
• have been told that you have a severe increase of potassium,
sodium or chloride in your blood
• have severely impaired liver function
• have severe heart failure
• have severe problems with your blood clotting
• have received an organ transplant.

For single use only.

Volulyte 6% Infusionslösung
Volulyte 6% oplossing voor infusie
Volulyte 6% solution for infusion
Volulyte 6% Solution for Infusion
Volulyte 6%
Volulyte
Volulyte 6% infusioonilahus
Volulyte 60 mg/ml infuusioneste, liuos
Volulyte 6% Infusionslösung
Volulyte 6% Solution for Infusion
Volulyte 6% oldatos infúzió
Volulyte 6% Solution for Infusion
Volulyte 60 mg/ml innrennslislyf, lausn
Volulyte 6% Soluzione per infusione
Volulyte 6% infuzinis tirpalas
Volulyte 6% škidums infuzijam
Volulyte 6% Infusionslösung
Volulyte 6% Solution for Infusion
Volulyte 6% oplossing voor infusie
Volulyte 60 mg/ml infusjonsvæske, oppløsning
Volulyte 6%
Volulyte Solução para Perfusão
Volulyte 6%, solutie perfuzabila
Volulyte 60 mg/ml infusionvätska, lösning
Volulyte 6%, infúzny roztok
Volulyte 60 mg/ml raztopina za infundiranje
Volulyte 6% solución para perfusión
Volulyte 6% Solution for Infusion

The product should be used immediately after first opening.
Any unused product or waste material should be disposed of in accordance
with local requirements.
Use only clear, particle-free solutions and undamaged containers.
Remove the overwrap from the Polyolefin (freeflex) bag prior to use.

Warnings and Precautions
It is important to tell your doctor if you have:
• impairment of your liver function
• problems with your heart or circulation
• blood clotting (coagulation) disorders
• problems with your kidneys
• increased potassium, sodium, magnesium, chloride or alkaline levels
in your blood (hyperkalaemia, hypernatraemia, hypermagnesaemia,
hyperchloraemia)

This leaflet was last revised in 02/2016.

5

6

1

V005

11.02.2016

068 7431/ 03 UK

0687431_03_UK_Volulyte_6%:0687431_03_UK_Volulyte_6%

0687431_03_UK_Volulyte_6%:0687431_03_UK_Volulyte_6%

11.02.2016

16:41 Uhr

Seite 4

Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you
will be monitored closely to detect early signs of an allergic reaction when
you receive this medicine.

3. How to use Volulyte

Mode of administration
You will receive this medicine by infusion into a vein (intravenous drip). The
speed of infusion, along with the amount of solution infused, will depend on
your specific requirements, the disease for which the product is being used,
and by reference to maximum daily dose.

Surgery and trauma:
Your doctor will consider carefully if this medicine is suitable for you.
Your doctor will adjust the dose of Volulyte carefully in order to prevent fluid
overload. This will be done especially if you have problems with your lungs
or with your heart or circulation.
The nursing staff will also take measures to observe your body's fluid
balance, blood salt level, and kidney function. If necessary you may receive
additional salts.
Volulyte is contraindicated if you have kidney impairment or kidney injury
requiring dialysis.

For MT: to The Medicines Authority at the following contact details:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
G˚R-1368 G˝ira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

Use in children
There is only limited experience of the use of this medicine in children.
Therefore it is not recommended to use this medicine in children.

If impaired kidney function occurs during therapy:
If the doctor detects first signs of kidney impairment he/she will stop giving
you this medicine. In addition your doctor may need to monitor your kidney
function for up to 90 days.

If you have received more Volulyte than you should
Your doctor will ensure that you receive the right amount of Volulyte.
However, different people need different doses, and if the dose does
prove too much for you, your doctor may stop Volulyte immediately and, if
necessary, administer a medicine that removes water from the body (diuretic).

If you are given Volulyte repeatedly your doctor will monitor the ability of your
blood to clot, bleeding time and other functions. In case of an impairment
of the ability of your blood to clot, your doctor will stop giving you this
medicine.

By reporting side effects you can help provide more information on the
safety of this medicine.

If you have any further questions on the use of this product, please ask your
doctor or pharmacist.
4. Possible side effects

Like all medicines, Volulyte can cause side effects, although not everybody
gets them.

5. How to store Volulyte

Common (may affect up to 1 in 10 people)
• Itching is a known side effect of hydroxyethyl starches when used over
long periods of time and at high doses.
• Other effects are associated with the dilution of the blood, which occurs
at high dosages, such as prolonged blood clotting time.
• The level of the enzyme serum amylase can rise during administration of
hydroxyethyl starch and can interfere with the diagnosis of inflammation
of the pancreas (pancreatitis). However, in this case the elevated serum
amylase level must not be considered diagnostic of pancreatitis.

Children
The safety of this product has not been assessed in children. Data are
limited in children, therefore it is recommended not to use HES products in
this population.
Other medicines and Volulyte
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines. To date, Volulyte is not known to have any interactions with
other medicines.

Rare (may affect up to 1 in 1,000 people)
• Medicinal products containing hydroxyethyl starch may lead to severe
allergic reactions (reddening of the skin, swelling of the throat, and difficult
breathing, mild influenza like symptoms, low or high heart rate, fluid in the
lungs not caused by heart problems).
• After administration of hydroxyethyl starch disturbances of blood clotting
can occur depending on the dose.

Volulyte with food and drink
Volulyte is not known to have any negative effect when given at the same
time as food or drink.
Pregnancy and breast-feeding
For Volulyte no clinical data on exposed pregnancies are available. The safety
of the product in pregnant and breast-feeding women has not been
investigated. There are limited clinical study data available from the use of a
single dose of HES 130/0.4 (6%) in 0.9% sodium chloride in pregnant
women undergoing caesarean section with spinal anaesthesia. No negative
influence of HES 130/0.4 (6%) in 0.9% sodium chloride on patient safety
could be detected; a negative influence on the neonate could also not be
detected.

Your doctor or nurse will ensure that the solution is clear, free from particles, the
container undamaged and the overwrap is removed from the polyolefine
(freeflex) bag before use.
The solution should be used immediately after opening, and any solution
remaining after treatment should be discarded. For single use only.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to of throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack
and other information

Electrolytes:
Na+
K+
Mg++
Cl–
CH3COO–

For UK: via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

3

What Volulyte contains
1000 ml solution for infusion contain:
Active substances:
Poly(O-2-hydroxyethyl)starch (Ph. Eur.)
– Molar substitution: 0.38 – 0.45
– Mean molecular weight (Mw): 130,000 Da
(manufactured from waxy maize starch)
Sodium acetate trihydrate
Sodium chloride
Potassium chloride
Magnesium chloride hexahydrate

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly:

Driving and using machines
After receiving Volulyte, your ability to drive a car or operate machinery will
not be affected.

• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not freeze.
Do not use Volulyte after the expiry date which is stated on the label. The
expiry date refers to the last day of that month.

Frequency not known (cannot be estimated from the available data)
• Kidney injury
• Liver injury

Your doctor will only give Volulyte after having weighed the benefits versus
the potential risk to the baby.

2

FREEPOST
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel.: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie.

Dosage
Your doctor will decide on the correct dose for you to receive.
Your doctor will use the lowest possible effective dose and will not
infuse Volulyte for more than 24 hours.
The maximum daily dose is 30 ml/kg for Volulyte.

In addition it will be ensured that you receive enough fluids.

If you are undergoing open heart surgery and you are on a heart-lung
machine to assist in pumping your blood during the surgery, the
administration of this solution is not recommended.

For IE: Reports may be made by following the links to the online reporting
option accessible from the IMB homepage, or by completing the
downloadable report form also accessible from the IMB website, which may
be completed manually and submitted to the IMB via freepost, to the
following address:

Volulyte will be given by, or under the direct supervision of, your physician,
who will closely control the amount of Volulyte given to you.

4

60.00 g

4.63 g
6.02 g
0.30 g
0.30 g
137.0 mmol/l
4.0 mmol/l
1.5 mmol/l
110.0 mmol/l
34.0 mmol/l

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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